Clinical trial · Interventional
CD19-BAFF CAR-T Cells Therapy for Patients With Relapsed / Refractory B-cell ALL and B-cell NHL
A Study of CD19-BAFF CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell ALL and B-cell NHL
NCT06346912CI-TRIAL-00077104recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Clinical Trial for the safety and efficacy of CD19-BAFF CAR-T cells therapy for refractory/relapsed B-cell acute lymphoblastic leukemia and B-cell non-Hodgkin lymphoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia,B-Cell | B Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Non-hodgkin Lymphoma,B Cell | B-Cell Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD19-BAFF Targeted CAR T-cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Administration of CD19-BAFF Targeted CAR T-cells
- description
- Dose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.
- interventionNames
- Biological: CD19-BAFF Targeted CAR T-cells
Primary outcomes (2)
- measure
- Dose-limiting toxicity (DLT)
- timeFrame
- Up to 28 years after Treatment
- description
- Adverse events assessed according to NCI-CTCAE v5.0 criteria
- measure
- Incidence of treatment-emergent adverse events (TEAEs)
- timeFrame
- Up to 2 years after Treatment
- description
- Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Gender unlimited,18\< Age; * 2\. Patients diagnosed with B-cell acute lymphoblastic leukemia through histological or immunophenotyping tests; The clear diagnosis of B-cell non Hodgkin's lymphoma by cellular or histopathological examination mainly includes diffuse large B-cell lymphoma, follicular lymphoma, and mantle cell lymphoma * 3\. Relapsed or refractory CD19+ B-ALL (meeting one of the following conditions): 1. CR not achieved after standardized chemotherapy; 2. CR achieved following the first induction, but CR duration is less than 12 months; 3. Ineffectively after first or multiple remedial treatments; 4. 2 or more relapses; * 4\. The number of primordial cells (lymphoblast and prolymphocyte) in bone marrow is \>5% (by morphology), and/or \>1% (by flow cytometry); * 5\. Philadelphia-chromosome-negative (Ph-) patients; or Philadelphia-chromosome-positive (Ph+) patients who cannot tolerate TKI treatments or do not respond to 2 TKI treatments; * 6\. Relapsed or refractory B-NHL (meeting one of the following conditions): 1. No response or relapse after second-line or above chemotherapy regimens; 2. Primary drug resistance; 3. Relapse after auto-HSCT; * 7\. At least one assessable tumor lesion per Lugano 2014 criteria; * 8\. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L; * 9\. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%; * 10\. No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%; * 11\. Estimated survival time ≥ 3 months; * 12\. ECOG performance status 0 to 2; * 13\. Patients or their legal guardians volunteer to participate in the study and sign the informed consent. Exclusion Criteria: * 1\. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases; * 2\. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past; * 3\. Pregnant/lactating women, or male or female patients with fertility who are unwilling to take effective contraceptive measures during the study period or at least 6 months after the last cell infusion * 4\. Patients with HIV infection; * 5\. Active infection of hepatitis B virus or hepatitis C virus; * 6\. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal; * 7\. Other uncontrolled diseases that were not suitable for this trial; * 8\. Individuals who have received CAR-T therapy, CAR-NK therapy, or any other gene modified cell therapy product within 6 months; * 9\. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
References
Publications (0)
Data not yet available
No reference posted for this study.